Investigator Certification

  • Overview
  • Benefits
  • Why Work With NSF?

NSF can review your company’s investigation reports and help your team improve its investigations and reports. Often good work was done by an investigator but it may not be reflected in the content of the written investigation report. Using an agreed-upon rubric as to what constitutes a good investigation report, our pharmaceutical consultants will review (mentor) and assess the work of investigators. Once an investigator demonstrates that they have attained a consistent skill level in conducting investigations and writing investigation reports, we grant NSF investigator certification.

Benefits

NSF’s approach results in more in-depth investigations, greatly improved investigation reports and, ultimately, much greater confidence that the company’s investigation system is working effectively. The overall outcome is fewer regulatory inspection concerns and many fewer reoccurring issues.

Why Work With NSF?

This case study illustrates the benefits of working with NSF’s pharmaceutical consultants. A U.S.-based contract manufacturing organization experienced a large spike in incident investigations following plant shutdown. It wanted experienced help with addressing the backlog of investigations, with a particular focus on the difficult ones.

Objectives

Our objective was to resolve as many investigations as possible in two months.

Approach/Methodology

NSF was embedded on-site Monday – Friday working on a variety of investigations and following the client’s process. NSF also provided mentoring to several employees new to the investigation process on technical writing, investigation mindset and use of root cause tools.

Outcomes/Benefits to Client (ROI)

We directly assisted in the closure of over 10 overdue and difficult investigations.

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